The alert is serious. In an open letter addressed on March 9, 2026 to the ANSM and the High Authority of Health (HAS), the medical journal Prescribe calls for the definitive withdrawal of nicorandil from the French market.
Used to treat angina, this vasodilator is in the hot seat due to particularly disabling adverse effects.
Treatment of angina under close monitoring
Nicorandil is a medicine used to reduce the symptoms of stable angina. This is chest pain linked to a lack of blood supply to the heart.
In France, it is reserved for patients whose symptoms are poorly controlled or who cannot tolerate first-line treatments (beta blockers or calcium antagonists).
However, its use remains massive: in 2024, around 71,000 patients will have used this treatment. This represents nearly a million boxes reimbursed by Health Insurance. A volume considered worrying by experts, while the effectiveness of the drug in preventing stress attacks has not been demonstrated.
Serious ulcerations that are too often ignored
The main danger of nicorandil lies in its ability to cause chronic and painful ulcerations. A French study identified 62 cases between 2017 and 2024. A figure probably underestimated because many cases are not reported to the authorities.
These sores are not limited to the mouth; they can affect:
- The skin, particularly on the lower limbs;
- The mucous membranes (mouth, intestine, anus, vagina);
- More rarely, the cornea, at the level of the eye.
The major problem is the delay in diagnosis. As the review points out Prescribethese ulcers “sometimes evolve for months, often because the role of nicorandil is not considered“. Without stopping the medication, healing is impossible, even with intervention.
What are the signs that should alert you?
If you take this molecule, pay attention to the appearance of symptoms such as red eyes, persistent sores (mouth, skin, anal area), blood in the stools or rapid weight loss.
In these situations, an emergency consultation is essential to consider another treatment.
Dr Gérald Kierzek’s opinion on this molecule
“Nicorandil is a last-line drug used to treat stable angina, but it presents serious risks mainly related to skin and mucosal ulcerations. These adverse effects justify increased vigilance, especially in elderly or polymedicated patients. he confirms first of all.
The doctor also specifies the procedure to follow for the patients concerned:
“A treatment should not be stopped unilaterally without medical advice, because nicorandil is reserved for cases refractory to beta-blockers or calcium antagonists. On the other hand, in the event of any sign of ulceration (pain, persistent wound), stop immediately and consult a doctor for an urgent cardiological re-evaluation. Healing generally occurs within weeks to months after stopping.”
Towards a delisting or a ban?
Finally, despite repeated alerts from the ANSM since 2010, nicorandil remains reimbursed at 65% by Social Security. For
Prescribethis situation has become “incomprehensible”.
The review considers that the drug exposes patients to a “loss of opportunity”, especially since safer alternatives, such as nitrate derivatives, exist.
For his part, Dr Kierzek encourages dialogue with specialists. “It is imperative to discuss with your cardiologist about another treatment adapted to your angina. Such as sustained-release nitrates, such as ivabradine, ranolazine or adjustment of first-line treatments. In France, several generics remain available, but their use is strictly regulated.
The ANSM, finally, insists on a personalized re-evaluation before any continuation or change of treatment.